MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD LUER-LOCK CONNECTOR FOR USE WITH NEEDLE-FREE PORTS; INTRAVASCULAR ADMINISTRATION SET

Model Number	515202
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd luer-lock connector for use with needle-free ports was damaged, but still operable.The following information was provided by the initial reporter: " it was reported luer lock disconnection.".
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary no sample or photo of the used connector was provided to our quality team.A device history review was performed for the reported lot 2105208, no deviations or non-conformities were identified during the manufacturing process that could have contributed to the alleged defect.Five retained samples were used for further evaluation.The product was visually inspected and no damage or defects were observed.Samples were functionally tested by connecting a sample syringe and injector to a sample protector along with the vial according to the instructions for use.Liquid was successfully aspirated from the vial and then the injector was connected to the retained sample connectors.In all cases, the liquid could flow correctly from the syringe through the injector and the connector without problem and without resistance.The product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification of flow rate and confirmation that all critical parts are within specifications, all have been checked.Records for the reported lot and the results were found to be acceptable.Based on the information available, we are unable to determine a root cause at this time.
Event or Problem Description
It was reported that bd luer-lock connector for use with needle-free ports was damaged, but still operable.The following information was provided by the initial reporter: " it was reported luer lock disconnection.".

• Brand Name: BD LUER-LOCK CONNECTOR FOR USE WITH NEEDLE-FREE PORTS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13099660
• Report Number: 3003152976-2021-00864
• Device Sequence Number: 4192273
• Product Code: ONB
• UDI-Device Identifier: 30382905152024
• UDI-Public: 30382905152024
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2025
• Device Model Number: 515202
• Device Catalogue Number: 515202
• Device Lot Number: 2105208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown